Status:

COMPLETED

Direct Application of Systane Complete to Contact Lenses

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

Alcon Research

Conditions:

Dry Eye

Contact Lens Complication

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically fo...

Detailed Description

Soft contact lenses are the ideal vision correction choice for many patients because soft contact lenses allow patients to have better and less restricted vision, they allow for an increased ability t...

Eligibility Criteria

Inclusion

  • Daily disposable contact lens wearers
  • 20/30 visual acuity or better
  • Self-report contact lens discomfort
  • Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

Exclusion

  • Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
  • Non-compliant daily disposable contact lens wearers
  • Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
  • History of ocular surgery within the past 12 months
  • History of severe ocular trauma
  • History of active ocular infection or inflammation
  • Isotretinoin-derivatives use
  • Ocular medication use
  • Pregnant or breast feeding

Key Trial Info

Start Date :

May 28 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 20 2019

Estimated Enrollment :

73 Patients enrolled

Trial Details

Trial ID

NCT03848221

Start Date

May 28 2019

End Date

October 20 2019

Last Update

October 8 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

Lindenhurst Eye Physicians & Surgeons, P.C.

Babylon, New York, United States, 11702

3

Southern College of Optometry

Memphis, Tennessee, United States, 38104